Detecting variations in glycan profiles that affect efficacy or immunogenicity
29 Apr 2026
Quality Control & Characterization
- What level of glycan shift is considered clinically meaningful after pivotal trials, and how should that threshold be justified in the absence of new clinical data?
- When analytical comparability is marginal but functional and PK data are unchanged, what ultimately drives regulatory acceptance or rejection?
- For Fc-silenced antibodies, where effector function is intentionally eliminated, what should regulators expect glycans to still control for—PK, stability, immunogenicity, or consistency only?
- In Fc-silenced molecules, does demonstrating lack of functional impact sufficiently de-risk glycan changes, or is uncertainty around immunogenicity still the primary concern?
- How should sponsors articulate comparability risk when glycan changes are mechanistically disconnected from MoA but occur late enough to threaten approval timelines?
Industry Expert
